BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 19709169 · Received July 10, 2024

    Report

    Report Number
    3001421318-2024-01650
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    July 3, 2024
    Report Date
    October 24, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. THE REVIEW OF THE COMPLAINT DEMONSTRATED THAT THERE WAS NON MALFUNCTION WITH THE DEVICE HAMILTON-C6 WHICH WAS FUNCTIONING WITHIN THE INTENDED SPECIFICATIONS AND TOLERANCES.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:O2 MIXER IN THE SYSTEM TEST SHOW HIGHER VALUES THAN SET.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:O2 MIXER IN THE SYSTEM TEST SHOW HIGHER VALUES THAN SET.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:O2 MIXER IN THE SYSTEM TEST SHOW HIGHER VALUES THAN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133433 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown